CAFC Affirms Finacea Gel Infringement Under Doctrine Of Equivalents

In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents still lives, that not every claim amendment will give rise to prosecution history estoppel, and that formulation patents can provide valuable protection for approved pharmaceutical products. Continue reading this entry

USPTO 101 Guidance: Microneedles Versus Prosthetic Devices

When I first wrote about the new natural products Subject Matter Eligibility Examples issued by the USPTO on May 4, 2016, I noted a puzzling difference between the treatment of a claim reciting a vaccine coated on a microneedle device versus a claim reciting a vaccine formulated in a cream carrier. Suzannah Sundby at Canady + Lortz LLP has pointed out another inconsistency: the USPTO’s treatment of a prosthetic device coated with a naturally-occurring mineral. Whether these differences are accidental or intentional, they reflect the inherent difficulty of applying current patent eligibility paradigms to specific claims.

Prosthetic Device—Eligible Under Streamlined Analysis

The December 16, 2014 Federal Register Notice explaining the USPTO’s 2014 Interim Guidance on Patent Subject Matter Eligibility included the following guidance:

For purposes of efficiency in examination, a streamlined eligibility analysis can be used for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it. Such claims do not need to proceed through the full analysis herein as their eligibility will be self-evident. ….

[A] claim that recites a nature-based product, but clearly does not attempt to tie up the nature-based product, does not require a markedly different characteristics analysis to identify a “product of nature” exception. As an example, a claim directed to an artificial hip prosthesis coated with a naturally occurring mineral is not an attempt to tie up the mineral.

While the December 2014 set of examples did not include such a claim, this guidance plainly indicates that a claim directed to an artificial hip prosthesis coated with a naturally occurring mineral could be found eligible under a streamlined analysis.

Cream Carrier—Eligible Under Markedly Different Analysis

The May 2016 Subject Matter Eligibility Examples include the following claim in Example 28:

4. A vaccine comprising:
Peptide F; and
a pharmaceutically acceptable carrier selected from the group consisting of a cream, emulsion, gel, liposome, nanoparticle or ointment.

The claim is determined to be eligible based on a “markedly different” analysis, because “[t]he claimed cream has different structural and physical characteristics than its naturally occurring components,” including properties that make it “adhere to a patient’s skin or mucous membranes much longer.” Because the claim is determined to be eligible at Step 2A of the USPTO’s framework, it is not subject to the “significantly more” analysis of Step 2B.

Microneedle Device—Eligible Under Significantly More Analysis

The May 2016 Subject Matter Eligibility Examples include the following claim in Example 28:

7. A vaccine delivery device comprising a microneedle array that is coated with a vaccine comprising Peptide F.

Rather than determining that the claim is eligible because, like the mineral-coated prosthetic device, it “clearly does not attempt to tie up the nature-based product,” the example subjects the claim to a full analysis. Indeed, the claim is said to fail the “markedly different” test because there is no indication that isolating the peptide from the virus or coating it on the microneedle array results in any different structural or functional characteristics. The claim is found eligible under the “significantly more” test, but only because “at the time the application was filed” it was not “conventional” to use microneedle arrays to deliver vaccines.

Figuring Out The New Examples

On May 25, 2016 I will be discussing the new examples with Raul Tamayo (Senior Legal Advisor Office of Patent Legal Administration at the USPTO) and Kevin Noonan (McDonnell Boehnen Hulbert & Berghoff LLP) on an IPO Chat Channel program. I plan to ask Mr. Tamayo to explain the USPTO’s reasoning behind these examples, and hope you will join us as we figure out the new USPTO 101 guidance.

Amgen And Sandoz Do The Biosimilar Patent Dance Over Neulasta

Amgen Inc. has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Sandoz Inc. seeking approval of a biosimilar version of Neulasta® infringes two of its patents. According to the complaint, the parties followed the steps of the biosimilar patent dance and agreed which patents should be litigated. Amgen has asserted one of the patents against Sandoz in a BPCIA suit stemming from Sandoz’s Neupogen® biosimilar application, and has asserted the other patent against Apotex, Inc. in a BPCIA suit stemming from Apotex’s Neulasta® biosimilar application.  Continue reading this entry

New USPTO Guidance On Patent Eligibility Of Natural Products

The new USPTO patent eligibility examples include two examples for “natural products” based inventions which appear to be consistent with the examples provided in the December 2014 set of patent eligibility examples. Although the new examples include additional discussion and guidance that could be helpful in some cases, they largely remain perplexing. Unfortunately, although the new diagnostic methods examples appear to take a stand against unreasonable court decisions, the new natural products examples continue to rely on Funk Brothers for a guiding principle. Continue reading this entry

New USPTO Guidance On Patent Eligibility Of Diagnostic Methods

The patent eligibility examples published by the USPTO on May 5, 2016 include two new examples relating to diagnostic methods and two new examples relating to “nature-based” products. This article will consider the diagnostic methods examples and ask whether they are consistent with recent Federal Circuit decisions, or whether the USPTO is taking a stand against the court’s recent decisions invalidating diagnostic method patents. Continue reading this entry